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The WeSensor is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.

The WeSensor is an intraoral digital x-ray sensor. It comprises three components: (1) an intraoral digital X-ray sensor which connects to a PC via a USB port; (2) WeSensor Software package; and (3) a sensor holder as an accessory.

The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non- sterile.

The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Tie-On or Ear Loops way for wearing, and they all has Nose Piece design for fitting the face mask around the nose. The outer layer is blue, and the colorant material is identified as Phthalocyanine Blue , CAS number: 147-14-8. The proposed device(s) are manufactured with three layers. the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, tie-on, is held in place over the uers's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene. The model of proposed device, ear loops, is held in place over the uers's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

UNiPACK Barrier Sleeve and Barrier Film and UNiGlide Barrier Envelope are intended to be used as a barrier to cover dental instruments. This device is non-sterile and intended for single patient use only.

The UNIPACK Barrier Sleeve and Barrier Film consist of various sizes and shapes of polyethylene covers which are positioned on various small hand-held dental instruments such as handpieces, curing lights, air/water syringes, and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument trays, x-ray heads, etc. The devices are sold non-sterile, prepackaged, and are for single use only.

The disposable PACK & PROPER Ear-Thermometer Prove Cap is used to protect probe of ear thermometer and prevent cross-infection.

Pack & Proper, Ear-Thermometer Probe Cap

A Surgical Mask is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate materials.

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The MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH is intended to be used to enclose another medical device that is to be sterilized by a health provider by steam or ethylene oxide (EtO). It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

The MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH is a device composed of medical paper. It is a bleached wet strength paper conforming to recognized material standards and can be sterilized by steam, ethylene oxide gas and irradiation.

The intended use of these sterile single use devices is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy or for tracheal irrigation or lavage. The intended use indication is identical to those devices to which substantial equivalence is claimed. The use of these devices for inhalation therapy is well-established.

The single-use device is in a color-coded unit blow-fill-sealed container with liquid contents as labeled for inhalation therapy. The device contains no preservative and is sterile and pyrogen-free. The single-use containers are embossed with identifying product text and level markings. The finished device product configuration characteristics of these inhalation devices are similar to those of the predicate devices.

The intended use of these sterile single use devices is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy or for tracheal irrigation or lavage. The intended use indication is identical to those devices to which substantial equivalence is claimed. The use of these devices for inhalation therapy is well-established.

The single-use devices are color-coded unit blow-fill-sealed containers with liquid contents as labeled for inhalation therapy. The devices contain no preservative. They are sterile and pyrogen-free. | CONTENTS | VOLUME | CONTAINER | |------------------------------------------------|----------|------------------------| | 0.45% Sodium Chloride Inhalation Solution, USP | 3mL fill | Green / Embossed label | | 0.45% Sodium Chloride Inhalation Solution, USP | 5mL fill | Green / Embossed label | | 0.9% Sodium Chloride Inhalation Solution, USP | 3mL fill | Pink / Embossed label | | 0.9% Sodium Chloride Inhalation Solution, USP | 5mL fill | Pink / Embossed label |

The intended use of these sterile single use devices is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy or for tracheal irrigation or lavage. The intended use indication is identical to those devices to which substantial equivalence is claimed. The use of these devices for inhalation therapy is well-established.

The single-use devices are color-coded unit blow-fill-sealed containers with liquid contents as labeled for inhalation therapy. The devices contain no preservative. They are sterile and pyrogen-free.